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comparison of pomegranate peel extract capsule effect with prostabarij soft capsule in patients with benign prostate hyperplasia

Comparison of pomegranate peel extract oral formulation and soft capsule including Cucurbita pepo oil and vitamin E for treatment of benign prostate hyperplasia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200408046990N8
Enrollment
40
Registered
2021-09-23
Start date
2021-09-23
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benign prostate hyperplasia. Enlarged prostate without lower urinary tract symptoms

Interventions

Intervention 1: Intervention group: 3 capsules contain 250 mg of pomegranate peel extract, prepared in pharmaceutics laboratory of Mashhad pharmacy school, daily for 4 month. Intervention 2: Control g

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: age between 50-80 years Mild to moderate clinical diagnosis of BPH (patient has lower urinary (based on international prostate symptom score (IPSS)<18)

Exclusion criteria

Exclusion criteria: simultaneous use of BPH medications except tamsulosin use of supplements which existing in BPH such as saw palmetto, Quercetin vitamins having prostate or bladder cancer history of prostate surgery PSA>4mg/ml Post void residue (PVR)=200 ml history of allergy to pomegranate and its derivatives concomitant use of warfarin in both group and statins except rosuvastatin, tacrolimus, and cyclosporine in pomegranate group Patient dissatisfaction

Design outcomes

Primary

MeasureTime frame
PSA serum level. Timepoint: at the beginning of the study and after 4m. Method of measurement: Enzyme Immuno Assay.;Prostate size. Timepoint: at the beginning of the study and after 4m. Method of measurement: sonography.;Post void volume. Timepoint: at the beginning of the study and after 4m. Method of measurement: sonography.

Secondary

MeasureTime frame
Adverse drug reaction assessment e.g. low blood pressure. Timepoint: at the beginning of the study and monthly. Method of measurement: review and physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSepideh Elyasi

Mashhad University of Medical Sciences

elyasis@mums.ac.ir+98 51 3851 7357

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026